Last Updated: July 18, 2026

Generic Companies with Tentative Approvals for: terbinafine hydrochloride

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terbinafine hydrochloride Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Mylan	terbinafine hydrochloride	077136	EQ 250MG BASE	TABLET;ORAL
Gedeon Richter Usa	terbinafine hydrochloride	077065	EQ 250MG BASE	TABLET;ORAL
Roxane	terbinafine hydrochloride	077223	EQ 250MG BASE	TABLET;ORAL
Andrx Pharm	terbinafine hydrochloride	076713	EQ 250MG BASE	TABLET; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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